ED-A-HIST PSE description, usages, side effects, indications, overdosage, supplying and lots more!

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ED-A-HIST PSE

EDWARDS PHARMACEUTICALS, INC.

ED-A-HIST PSE TABLETS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredients (in each tablet) Purpose
Pseudoephedrine HCI 60 mg Nasal Decongestant
Triprolidine HCI 2.5 mg. Antihistamine

ED-A-HIST PSE Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

  • Do not exceed recommended dosage.

Do not use this product

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

  • excitability may occur, especially in children
  • may cause drowsiness
  • alcohol, sedatives and tranquilizers may increase drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever
  • new symptoms occur

If pregnant or breast-feeding, ask a health professional before use,

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over: 1 tablet every 4-6 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age: 1/2 tablet every 4-6 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor
Children under 6 years of age: Consult a doctor.

Inactive ingredients

FD&C Blue #2, FD&C Yellow #5, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate.

Contains FD&C Yellow No. 5 (tartrazine) as a color additive.

Questions or Comments?

Call 1-800-543-9560

Rev. 11/11

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC 00485-0210-01

ED A-HIST PSE TABLETS

Nasal Decongestant • Antihistamine

Each tablet contains:
Pseudoephedrine HCI       60 mg
Triprolidine HCI                2.5 mg

This bottle is not to be dispensed to consumer.
Dispense in a tight, light-resistant container
with a child-resistant cap.

Store at 59°-86°F (15°-30°C) (see USP Controlled Room Temperature].
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Manufactured for:
EDWARDS
Pharmaceuticals, Inc .
Ripley, MS 38663

100 tablets

ED-A-HIST PSE

ED-A-HIST PSE

PSEUDOEPHEDRINE HYDROCHLORIDE and TRIPROLIDINE HYDROCHLORIDE TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0485-0210
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Pseudoephedrine Hydrochloride Pseudoephedrine 60 mg
triprolidine hydrochloride TRIPROLIDINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 2
FD&C YELLOW NO. 5
MAGNESIUM STEARATE
cellulose, microcrystalline
sodium starch glycolate type a corn

Product Characteristics

Color Size Imprint Code Shape
GREEN 13 mm ED;PSE OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0485-0210-01 100 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-10-08


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Be sure to consult your doctor before taking any medication!
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